SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4— 510(k) K890963

Substantially Equivalent

Esaote Biomedica Elettronica

FDA 510(k) clearance K890963 for SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4, Substantially Equivalent on 1989-07-19. Applicant: Esaote Biomedica Elettronica.

Clearance details

Applicant: Esaote Biomedica Elettronica
Product code: Code IYO
Advisory panel: Radiology
Date received: 1989-02-27
Decision date: 1989-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.